Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

Not Applicable

Recruiting

• Conditions: Brain Tumors; Quality of Life; Brain Tumor, Pediatric
• Interventions: Behavioral: Acceptance and Commitment Therapy

• Registration Number: NCT04722237
• Lead Sponsor: Nottingham University Hospitals NHS Trust

Brief Summary

Background. Survivors of childhood brain tumours have the poorest health-related quality of life of all cancer survivors due to the multiple physical and psychological sequelae of brain tumours and their treatment. Remotely delivered Acceptance and Commitment Therapy (ACT) may be a suitable and accessible psychological intervention to support young people who have survived brain tumours.

Aims. This study aims to assess the feasibility and acceptability of remotely delivered ACT to improve quality of life among young brain tumour survivors.

Method. This study is a two-arm, parallel group, randomised controlled trial comparing ACT with waitlist control. Participants will be aged 11-24 years and survivors of brain tumours who have completed cancer treatment. Participants will be randomised to receive 12 weeks of ACT either immediately or after a 12-week wait. The durability of treatment effects will be assessed by further follow-up assessments at 24-, 36- and 48- weeks. The DNA-v model of ACT will be employed, which is a developmentally appropriate model for young people. Feasibility will be assessed using the proportion of those showing interest who consent to the trial and complete the intervention. A range of clinical outcome measures will also assess physical and mental health, everyday functioning, quality of life and service usage. Acceptability will be assessed using participant evaluations of the intervention, alongside qualitative interviews and treatment diaries analysed thematically.

Discussion. This study will provide an initial assessment of the value of remotely delivered ACT in supporting recovery and coping for young people after brain tumour treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-25
• Study Start: 2021-03-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Aged 11-to-24 years at the time of randomisation
• Received treatment for a brain tumour at a participating Principle Treatment Centre
• Active brain tumour treatment is complete and their condition stable for at least six-months
• Have sufficient cognitive ability to engage with ACT sessions as judged by the clinician at baseline assessment
• competent to provide informed consent (participants aged 16 or over) or assent (participants aged 11-15)
• Parent/carer competent to provide informed consent (for participants aged 11-15)

Read More

Exclusion Criteria

• Received a structured behavioural intervention within six-months prior to study recruitment
• Previous or current alcohol/substance dependence, psychosis, suicidality, or eating disorder
• Moderate or severe intellectual disability, confirmed through researcher judgement at screening through questions relating to school type and previous diagnoses
• Immediate risk to self or others
• The patient or their parent/carer is not able to speak, read or write English

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Acceptance and Commitment Therapy	Acceptance and Commitment Therapy	Receiving 6-to-12 weekly sessions of Acceptance and Commitment Therapy immediately after allocation. Each session will be up to one hour in length.

Primary Outcome Measures

Name	Time	Method
Session attendance rate	assessed at 6-month follow-up	The session attendance rate compared to feasibility benchmarks
Treatment completion rate	assessed at 6-month follow-up	The proportion of patients showing interest who then consent to the trial and complete the intervention
The credibility/expectancy questionnaire	Assessed at session 2	Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
The experience of service questionnaire	Assessed at 6-month follow-up.	A questionnaire used nationally in child and adolescent mental health services completed by patients and parents/carers (if under 16) to assess participants' experience of the intervention. An additional item has been added to the experience of service questionnaire to assess video-conferencing treatment satisfaction. Minimum score = 0; maximum score = 20. Higher scores indicate better outcome.

Secondary Outcome Measures

Name	Time	Method
World Health Organisation wellbeing index 5-items	assessed at 3, 6, 9 and 12-month follow-up	A brief self-reported assessment of wellbeing and mental health. Minimum score = 7 score; maximum = 49. Higher scores indicate worse outcome. Minimum score = 0; maximum score = 49. Higher scores indicate worse outcome.
Acceptance and Action Questionnaire II	assessed at 3, 6, 9 and 12-month follow-up	A brief 7-item self-report measure assessing psychological inflexibility, which is the central treatment target for ACT. Validated for use among patients aged 16 and over. Minimum score = 7; maximum score = 49. Higher scores indicate worse outcome.
Avoidance and Fusion Questionnaire for Youth 8-items	assessed at 3, 6, 9 and 12-month follow-up	A brief self-report measure of psychological inflexibility, for children (11 to 15 year old participants). Minimum score = 0; maximum score = 32. Higher scores indicate worse outcome.
Patient Health Questionnaire 9-items	assessed at 3, 6, 9 and 12-month follow-up	Assesses symptoms of depression using self-reported 4-point Likert scales based on diagnostic criteria for major depression. Minimum score = 0; maximum score = 27. Higher scores indicate worse outcome.
Generalised Anxiety Disorder assessment 7-items	assessed at 3, 6, 9 and 12-month follow-up	A brief self-reported measure of generalised anxiety symptoms using 4-point Likert scales based on diagnostic criteria. Minimum score = 0; maximum score = 21. Higher scores indicate worse outcome.
Euroqol 5-dimensions 3-levels	assessed at 3, 6, 9 and 12-month follow-up	a self-reported assessment of five key dimensions of health-related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The youth version will be used for participants under 16 years old. Minimum score = 0; maximum score = 1. Higher scores indicate better outcome.
Strengths and Difficulties Questionnaire 25-item	assessed at 3, 6, 9 and 12-month follow-up	A patient and parent/carer-completed brief measure of behavioural and emotional functioning. Minimum score = 0; maximum score = 50. Higher scores indicate better outcome.
Experiential interviews	assessed at 3- and 6-month follow-up	Participant experiences of treatment as described in semi-structured qualitative interviews
Patient-Reported Outcomes Measurement Information System, Satisfaction with Social Roles and Activities	assessed at 3, 6, 9 and 12-month follow-up	Assesses satisfaction with performing one's usual social roles and activities. It, therefore, acts as a measure of social engagement which can be heavily impacted by brain tumour diagnosis and treatment. Minimum score = 8; maximum score = 40. Higher scores indicate worse outcome.
Client Service Receipt Inventory	assessed at 3, 6, 9 and 12-month follow-up	A research instrument developed to collect information on service receipt, service-related issues and income. In addition, the Client Service Receipt Inventory collects information on school attendance in the 3-months prior to assessment.

Trial Locations

Locations (1)

Sophie Thomas; 🇬🇧 Nottingham, United Kingdom